RAGUVARMAN MAHADEVAN
Ahmedabad
Summary
- Microbiologist with 15 years of QC experience in cGMP-compliant pharma/biopharma, specializing in testing of sterile injectables (PFS, vials, cartridges), APIs, and non-sterile OSDs
- Led development and commissioning of microbiology labs, including vendor management and qualification (URS, DQ, IQ/OQ/PQ) of equipment and instruments
- Expertise in BET, sterility, bioburden, method validation, environmental monitoring, equipment qualification, and QMS (deviations, OOS, CAPA) using TrackWise and Q-Edge
- Strong leadership in aseptic practices, media fill studies, audits, data review, and continuous improvement initiatives
Overview
15
15
years of professional experience
Work History
Manager (QC Microbiology)
INTAS Pharmaceuticals (Biopharma Division)
Ahmedabad
10.2019 - Current
- Led 15-member GLP and QMS team to ensure regulatory compliance and establish microbiology laboratory.
- Managed method validation operations for equipment qualification and capital expenditure planning.
- Led quality management system activities encompassing change control, deviations, out-of-specification (OOS) results, corrective and preventive actions (CAPA), and quality risk management (QRM) while supporting aseptic validation and microbiological reporting.
- Coordinated external calibrations and technical agreements to enhance audit readiness.
Executive
Wockhardt Bio-AG
Dubai, Dubai
03.2018 - 09.2019
- Designed and commissioned microbiology laboratory compliant with US FDA, MHRA, and WHO standards.
- Assisted with project planning, cost analysis, and scheduling for effective execution.
Supported microbiology subject matter expert during regulatory inspections.
Facilitated capital expenditure approvals for laboratory equipment and instrumentation.
Senior Executive
Shilpa Medicare Limited
Jadcherla
11.2015 - 03.2018
- Managed QMS activities, including change control investigations, CAPA processes, and regulatory documentation management.
- Executed sterility method validation and microbiological equipment qualification to ensure compliance with industry standards.
- Facilitated microbiology expertise during US FDA, MHRA, and WHO inspections.
Junior Executive
Hospira Health Care India Private Ltd
Aurangabad
07.2013 - 11.2015
QAD Officer
Wockhardt Limited
Ankleshwar
08.2011 - 07.2013
Officer
ICPA Health Products Limited
Ankleshwar
11.2010 - 08.2011
Education
Master of Science - Microbiology
Urumu Dhanalakshimi College of Arts & Science
Tiruchi, TN01-2010
Bachelor of Science - Microbiology
Urumu Dhanalakshimi College of Arts & Science
Tiruchi, TN01-2008
Skills
- Regulatory compliance
- Method validation
- Quality management
- Project management
- Team leadership
- Problem solving
- Quality control procedures
- Project oversight
Languages
Tamil
First Language
English
Proficient
C2
Hindi
Upper Intermediate
B2
Interests
- Playing Cricket
- Listening Music
- Swimming
Timeline
Manager (QC Microbiology)
INTAS Pharmaceuticals (Biopharma Division)
10.2019 - Current
Executive
Wockhardt Bio-AG
03.2018 - 09.2019
Senior Executive
Shilpa Medicare Limited
11.2015 - 03.2018
Junior Executive
Hospira Health Care India Private Ltd
07.2013 - 11.2015
QAD Officer
Wockhardt Limited
08.2011 - 07.2013
Officer
ICPA Health Products Limited
11.2010 - 08.2011
Master of Science - Microbiology
Urumu Dhanalakshimi College of Arts & Science
Bachelor of Science - Microbiology
Urumu Dhanalakshimi College of Arts & Science